Optetrak Logic 02-012-44-2509Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862173515), received between Feb 22, 2023 and Jul 30, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0021-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT AN 81 YO FEMALE PATIENT, WHO HAD A RIGHT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. MILD OSTEOLYSIS WAS FOUND PRESENT. THE PATELLA EXHIBITED MEDIAL TO LATERAL WEAR ALONG TRACKING PATH. THE TIBIAL INSERT HAD MILD MEDIAL WEAR. ADDITIONAL WEAR ON THE POSTERIOR POST NOTED. THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. THE PATELLA AND LINER WERE EXCHANGED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISCARDED. THERE WAS NO DEVICE IMAGES PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 22671795 ↗
• InjuryJul 31, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 51 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING PLAINTIFF HAS EXPERIENCED DAILY PAIN AND DISCOMFORT IN HIS RIGHT KNEE WHICH HAS LIMITED HIS ACTIVITIES OF DAILY LIVING AND IMPACTED HIS QUALITY OF LIFE. PLAINTIFF HAS SUFFERED DEBILITATING INJURIES' AND DAMAGES, INCLUDING BUT NOT LIMITED TO PAIN AND DISCOMFORT; SWELLING; GAIT IMPAIRMENT; POOR BALANCE; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; BONE DAMAGE AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. AS A FURTHER DIRECT, PROXIMATE, AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPETRAK LOGIC DEVISE. PLAINTIFF WAS SUSTAINED AND WILL SUSTAIN FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE; REHABILITYATE, HOME HEALTH CARE; LOSS OF EARNING CAPACITY, MENTAL AND EMOTIONAL DISTRESS; AND PAIN AND SUFFERING.. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthrofibrosis; Balance Problems; Discomfort; Emotional Changes; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19872189 ↗
• InjuryJun 6, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 45 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND DISCOMFORT, LIMITED ACTIVITIES OF DAILY LIVING, IMPACTED QUALITY OF LIFE; DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND DISCOMFORT; SWELLING; GAIT IMPAIRMENT; POOR BALANCE; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; BONE DAMAGE; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE; FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE; REHABILITATION; HOME HEALTH CARE; LOSS OF EARNING CAPACITY; MENTAL AND EMOTIONAL DISTRESS; AND PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Emotional Changes; Implant Pain; Pain; Swelling/ Edema

  MAUDE report 19475759 ↗
• InjuryOct 2, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2018. THE PATIENT STARTED EXPERIENCING PAIN, SWELLING, INSTABILITY AND AN INABILITY TO BEAR WEIGHT ON LEFT KNEE. APPROXIMATELY 4 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. THIS IS BELIEVED TO BE DUE TO ACCELERATED POLYETHYLENE WEAR AND EARLY ASEPTIC LOOSENING. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. 1ST INVESTIGATION: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE COMPLAINT CANNOT BE CONCLUSIVELY DETERMINED; INSUFFICIENT INFORMATION. THE PATIENT HAS FILED A COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. (B)(4), AND PENDING IN THE EASTERN DISTRICT OF (B)(6). PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS ALLEGE THA

  Patient problems: Failure of Implant

  MAUDE report 17850184 ↗
• InjuryAug 25, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD PRIMARY RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2014. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2016, APPROXIMATELY 2 YEARS 8 MONTHS AFTER THEIR INITIAL IMPLANTATION. THE PATIENT HAS REPORTED HAVING SUFFERED INTENSE PAIN, INSTABILITY, AND A REVISION SURGERY AS A RESULT OF THIS EXACTECH DEVICE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULT

  Patient problems: Failure of Implant; Joint Laxity; Swelling/ Edema

  MAUDE report 17627106 ↗
• InjuryJul 25, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD PRIMARY LEFT KNEE REPLACEMENT ON (B)(6) 2013. THEY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 9 YEARS 7 MONTHS AFTER THEIR INITIAL IMPLANTATION. (B)(6) 2023 OP REPORT POSTOPERATIVE DIAGNOSIS: EARLY SIGNIFICANT OSTEOLYSIS AND WEAR STATUS POST TOTAL KNEE ARTHROPLASTY; COMPLICATIONS DUE TO INTERNAL ORTHOPEDIC DEVICE, IMPLANT, AND GRAFT; OTHER SECONDARY OSTEOARTHRITIS OF LEFT KNEE. SURGEON NOTED THAT THE PATIENT HAD A SIGNIFICANT EFFUSION, AND SIGNIFICANT POLYETHYLENE INDUCED SYNOVITIS. POLYETHYLENE WAS REMOVED AND DID SHOW SIGNIFICANT DAMAGE ON THE SUPERIOR SURFACE. FEMORAL COMPONENT WAS REMOVED WITHOUT ANY SIGNIFICANT BONE LOSS WITH DEBONDING AT THE CEMENT COMPONENT INTERFACE. THERE WAS A LARGE AREA OF OSTEOLYSIS IN THE MEDIAL FEMORAL CONDYLE WITH MAINTENANCE OF THE CORTICAL RIM AROUND TO THE SUPPORTIVE POSTERIOR PORTION. PATELLA WAS NOTED AS "NOT UNSTABLE". PATIENT WAS RETURNED TO RECOVERY IN STABLE CONDITION.

  Patient problems: Failure of Implant; Implant Pain; Joint effusion; Osteolysis; Synovitis

  MAUDE report 17389191 ↗
• InjuryFeb 22, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY THE LEGAL BRIEF, IN (B)(6) 2014, PATIENT UNDERWENT LEFT KNEE REPLACEMENT SURGERY WHERE SHE WAS IMPLANTED WITH AN OPTETRAK DEVICE. ON (B)(6) 2022, PATIENT UNDERWENT LEFT KNEE REVISION SURGERY DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE POLYETHYLENE INSERT.

  Patient problems: Failure of Implant

  MAUDE report 16421693 ↗